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Opinion/decision on a Paediatric investigation plan (PIP): Tofacitinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-000576-PIP02-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral solution
Decision date: 17/03/2017, Last updated: 27/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001904-PIP03-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 13/05/2022, Last updated: 26/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy- 10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,- 14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]- oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyldimethyl-phosphinate (MK-8669, or AP23573) (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: P/2/2010, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Gastro-resistant tablet, Age-appropriate dosage form, other, Age-appropriate dosage form for parenteral use
Decision date: 25/01/2010, Last updated: 22/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Etrasimod L-arginine (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002713-PIP01-19-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 29/09/2022, Last updated: 21/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): sotatercept (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002756-PIP01-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 29/09/2022, Last updated: 21/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adrenaline (epinephrine) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002749-PIP01-19-M02, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 09/09/2022, Last updated: 21/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Plasma kallikrein inhibitor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002723-PIP01-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 27/09/2022, Last updated: 21/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Etranacogene dezaparvovec (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002722-PIP01-19-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 21/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rozanolixizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002681-PIP01-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 29/09/2022, Last updated: 20/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vumerity, Diroximel fumarate (BIIB098) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002685-PIP02-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Gastro-resistant capsule, hard
Decision date: 29/09/2022, Last updated: 20/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zoliflodacin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002599-PIP01-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 09/09/2022, Last updated: 20/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xofluza, Baloxavir marboxil (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002440-PIP01-18-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension
Decision date: 09/09/2022, Last updated: 20/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000520-PIP02-13-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP